Utak Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Utak Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2022375
FEI Number2022375
NameUTAK LABORATORIES, INC.
Owner & OperatorUTAK LABORATORIES, I
Contact Address25020 AVENUE TIBBITTS --
Valencia CA 91355 US
Official Correspondent
  • Kevin M Kopp
  • x-661-2943935-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address25020 AVENUE TIBBITTS
VALENCIA, CA 91355 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
UTAK LABORATORIES, INC.
ALPRAZOLAM PLUS 2 ALP+ 2 V2 S SH 2025-01-23
UTAK LABORATORIES, INC.
ALPRAZOLAM PLUS 1 ALP+ 1 V2 S SH2025-01-23
UTAK LABORATORIES, INC.
IMIPRAMINE 1000 NG/ML IMIP 1000 S F UW2025-01-22
UTAK LABORATORIES, INC.
MD LABS 43 DRUGS LOW MD LABS 43 V2 LOW2025-01-21
UTAK LABORATORIES, INC.
MD LABS 43 DRUGS HIGH MD LABS 43 V2 HIGH2025-01-21
UTAK LABORATORIES, INC.
BUPRENORPHINE HYDROLYSIS QC 91801 U AL2025-01-21
UTAK LABORATORIES, INC.
HMSB LEVEL 3 V2 HMSB 3 V2 WB F MAYO2025-01-20
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 3 DOA 3 EXTBUF OF F MMC2025-01-20
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 2 DOA 2 EXTBUF OF F MMC2025-01-20
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 1 DOA 1 EXTBUF OF F MMC2025-01-20
UTAK LABORATORIES, INC.
VETERINARY USE ONLY BROMIDE 1.2 MG/ML UTAK-SC VET BRO 1.2 S SD2025-01-17
UTAK LABORATORIES, INC.
VETERINARY USE ONLY BROMIDE 0.5 MG/ML UTAK-SC VET BRO 0.5 S SD2025-01-17
UTAK LABORATORIES, INC.
BENZODIAZEPINES QC LEVEL 2 BENZO QC2 U ADX2025-01-17
UTAK LABORATORIES, INC.
BENZODIAZEPINES QC LEVEL 1 BENZO QC1 U ADX2025-01-17
UTAK LABORATORIES, INC.
VOLATILES PLUS 5 MG/DL VOL+ 5 MFCL2025-01-16
UTAK LABORATORIES, INC.
VOLATILES PLUS 50 MG/D VOL+ 50 MFCL 2025-01-16
UTAK LABORATORIES, INC.
VOLATILES PLUS 200 MG/DL VOL+ 200 MFCL2025-01-16
UTAK LABORATORIES, INC.
VOLATILES PLUS 10 MG/DL VOL+ 10 MFCL 2025-01-16
UTAK LABORATORIES, INC.
VOLATILES PLUS 100 MG/DL VOL+ 100 MFCL2025-01-16
UTAK LABORATORIES, INC.
COMP TOX I_05 25 COMP TOX I_05 252025-01-13
UTAK LABORATORIES, INC.
COMP TOX I_04 25 COMP TOX I_04 25 2025-01-13
UTAK LABORATORIES, INC.
COMP TOX I_03 25 COMP TOX I_03 252025-01-13
UTAK LABORATORIES, INC.
COMP TOX I_02 25 COMP TOX I_02 252025-01-13
UTAK LABORATORIES, INC.
COMP TOX I_01 25 COMP TOX I_01 25 2025-01-13
UTAK LABORATORIES, INC.
COTININE POS POS-217-2U 2025-01-10
UTAK LABORATORIES, INC.
KETAMINE POS POS-240-2U2024-12-27
UTAK LABORATORIES, INC.
RITALIN POS POS-219-2U2024-12-27
UTAK LABORATORIES, INC.
ETOH I_05 25 ETOH I_05 252024-12-27
UTAK LABORATORIES, INC.
ETOH I_03 25 ETOH I_03 252024-12-27
UTAK LABORATORIES, INC.
ETOH I_03 25 ETOH I_03 252024-12-27
UTAK LABORATORIES, INC.
ETOH I_02 25 ETOH I_02 252024-12-27
UTAK LABORATORIES, INC.
ETOH I_01 25 ETOH I_01 252024-12-27
UTAK LABORATORIES, INC.
BLANK WHOLE BLOOD 100ML 44600-WB(F) 100ML RH2024-12-19
UTAK LABORATORIES, INC.
TOXICOLOGY QC LEVEL 2 2024-12-03
UTAK LABORATORIES, INC.
TOXICOLOGY QC LEVEL 1 2024-12-03
UTAK LABORATORIES, INC.
ORAL TOXICOLOGY QC LEVEL 2 2024-12-03
UTAK LABORATORIES, INC.
ORAL TOXICOLOGY QC LEVEL 1 2024-12-03
UTAK LABORATORIES, INC.
BENZODIAZEPINES -25% BENZO -25 ADX2024-11-04
UTAK LABORATORIES, INC.
MORPHINE GLUCURONIDE MOR GLUC U HCMC2024-11-01
UTAK LABORATORIES, INC.
MPA LEVEL 1 MPA 1 S POTM2024-10-25
UTAK LABORATORIES, INC.
DRUGS OF ABUSE MID 3ML DAU MID V3 3ML U IPM2024-10-25
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LOW 3ML DAU LOW V3 3ML U IPM2024-10-25
UTAK LABORATORIES, INC.
DRUGS OF ABUSE HIGH 3ML DAU HIGH V3 3ML U IPM2024-10-25
UTAK LABORATORIES, INC.
ORAL FLUID UTAK ANTIPSYCH+ V4 OF F OT2024-10-25
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS QC 3 VORI+ QC 3 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS QC 2 VORI+ QC 2 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS QC 1 VORI+ QC 1 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS CAL 6 VORI+ CAL 6 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS CAL 4 VORI+ CAL 5 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS CAL 4 VORI+ CAL 4 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS CAL 3 VORI+ CAL 3 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS CAL 2 VORI+ CAL 2 SJCR2024-10-24
UTAK LABORATORIES, INC.
VORICONAZOLE PLUS CAL 1 VORI+ CAL 1 SJCR2024-10-24
UTAK LABORATORIES, INC.
PENTOBARBITAL LEVEL 2 PENTO 2 S UPMC2024-10-22
UTAK LABORATORIES, INC.
PENTOBARBITAL LEVEL 1 PENTO 1 S UPMC2024-10-22
UTAK LABORATORIES, INC.
DAU POSITIVE V3 DAU POS F V3 UVHS2024-10-17
UTAK LABORATORIES, INC.
DAU NEGATIVE V3 DAU NEG F V3 UVHS 2024-10-17
UTAK LABORATORIES, INC.
CERTIFIED DRUG FREE URINE CDF U L(1/2 GAL) JNC2024-10-11
UTAK LABORATORIES, INC.
VOLATILES HIGH VOL HIGH S ULH2024-10-10
UTAK LABORATORIES, INC.
DRUGS OF ABUSE QC A LEVEL 3 QC A3 OF F WHPM2024-10-09
UTAK LABORATORIES, INC.
DRUGS OF ABUSE QC A LEVEL 2 QC A2 OF F WHPM2024-10-09
UTAK LABORATORIES, INC.
DRUGS OF ABUSE QC A LEVEL 1 QC A1 OF F WHPM2024-10-09
UTAK LABORATORIES, INC.
NICOTINE PLUS LEVEL 2 90001 U F LTI2024-10-08
UTAK LABORATORIES, INC.
NICOTINE PLUS LEVEL 1 90000 U F LTI2024-10-08
UTAK LABORATORIES, INC.
DRUGS OF ABUSE POSITIVE V2 DAU POS V2 F UPMC2024-10-03
UTAK LABORATORIES, INC.
NICOTINE PLUS LEVEL 1 NICO+ 1 V2 F QC LC2024-10-01
UTAK LABORATORIES, INC.
BENZODIAZEPINES LEVEL 2 V3 BENZO L2 V3 U F UW2024-10-01
UTAK LABORATORIES, INC.
BENZODIAZEPINES LEVEL 1 V3 BENZO L1 V3 U F UW2024-10-01
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 1DRUGS OF ABUSE LEVEL 3 DOA 3 i2he OF F MMC2024-09-30
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 2 DOA 2 i2he OF F MMC2024-09-30
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 1 DOA 1 i2he OF F MMC2024-09-30
UTAK LABORATORIES, INC.
THC PLUS LEVEL 2 THC+ 2 V2 WB NJSP2024-09-26
UTAK LABORATORIES, INC.
THC PLUS LEVEL 2 THC+ 2 V2 U NJSP2024-09-26
UTAK LABORATORIES, INC.
THC PLUS LEVEL 1 THC+ 1 V2 WB NJSP2024-09-26
UTAK LABORATORIES, INC.
THC PLUS LEVEL 1 THC+ 1 V2 U NJSP2024-09-26
UTAK LABORATORIES, INC.
FENTANYL PLUS LEVEL 2 FENT+ 2 WB NJSP2024-09-26
UTAK LABORATORIES, INC.
FENTANYL PLUS LEVEL 2 FENT+ 2 V2 U NJSP2024-09-26
UTAK LABORATORIES, INC.
FENTANYL PLUS LEVEL 1 FENT+ 1 WB NJSP2024-09-26
UTAK LABORATORIES, INC.
FENTANYL PLUS LEVEL 1 FENT+ 1 V2 U NJSP 2024-09-26
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 4 DAU 4 NJSP2024-09-26
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 3 DAU 3 NJSP2024-09-26
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 2 DAU 2 V2 NJSP2024-09-26
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 1 DAU 1 V2 NJSP2024-09-26
UTAK LABORATORIES, INC.
CERTIFIED DRUG FREE URINE 88121-CDF(F)10 NJSP2024-09-26
UTAK LABORATORIES, INC.
RT3 LEVEL 3 RT3 3 S F PG2024-09-24
UTAK LABORATORIES, INC.
RT3 LEVEL 2 RT3 2 S F PG2024-09-24
UTAK LABORATORIES, INC.
RT3 LEVEL 1 RT3 1 S F PG2024-09-24
UTAK LABORATORIES, INC.
LEAD LEVEL 5 LEAD 5 WB F CH2024-09-23
UTAK LABORATORIES, INC.
LEAD LEVEL 4 V4 EAD 4 V4 WB F CH2024-09-23
UTAK LABORATORIES, INC.
LEAD LEVEL 3 V4 LEAD 3 V4 WB F CH2024-09-23
UTAK LABORATORIES, INC.
LEAD 2 V4 WB F CH LEAD LEVEL 2 V42024-09-23
UTAK LABORATORIES, INC.
ELISA LOW POSITIVE CONTROL ELISA LPC WB OSBI2024-09-23
UTAK LABORATORIES, INC.
ELISA HIGH POSITIVE CONTROL ELISA HPC WB OSBI 2024-09-23
UTAK LABORATORIES, INC.
AED QC LEVEL 3 V3 UTAK-SC AED V3 3 SD2024-09-19
UTAK LABORATORIES, INC.
AED QC LEVEL 2 V3 UTAK-SC AED V3 2 SD2024-09-19
UTAK LABORATORIES, INC.
BENZOYLECGONINE CAL SET POS-M150-2-32024-09-19
UTAK LABORATORIES, INC.
ZOLPIDEM POS POS-233-2U2024-09-19
UTAK LABORATORIES, INC.
TRICYCLICS POS POS-222-2U2024-09-19
UTAK LABORATORIES, INC.
MORPHINE POS POS-213-2U2024-09-19
UTAK LABORATORIES, INC.
SECOBARBITAL POS POS-210-2U2024-09-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Vi2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Li Tx Control2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Whole Blood Lead Controls2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Trace Elements Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Clonazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK STABBS Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Vancomycin Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Benzodiazepines Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Flurazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Disopyramide Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Pentobarbital Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Caffeine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Maprotiline Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Amoxapine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Salicylate Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Acetaminophen Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Barbiturates Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs II Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs I Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Anticonvulsants Control2007-12-05
UTAK LABORATORIES, INC.
UTAK LABORATORIES TOXICOLOGY CONTROL1991-04-12
UTAK LABORATORIES, INC.
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL1988-10-06
UTAK LABORATORIES, INC.
SERUM VANCOMYCIN TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
BENZODIAZEPINES TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
SERUM CLONAZEPAM TOXICOLOGY CONTROL1986-11-05
UTAK LABORATORIES, INC.
UTAK-STABBS TOXICOLOGY CONTROL1986-08-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS1983-07-28
UTAK LABORATORIES, INC.
FLURAZEPAM TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
CAFFINE TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
MAPROTILINE1983-07-26
UTAK LABORATORIES, INC.
AMOXAPINE 8-HYDRO-XYAMOXAPINE1983-07-26
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSNATS VI1983-07-19
UTAK LABORATORIES, INC.
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE1983-07-06
UTAK LABORATORIES, INC.
PENTOBARBITAL TOXICOLOGY CONTROL1983-07-06
UTAK LABORATORIES, INC.
TOXICOLOGY CONTROL1981-02-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL1980-05-02
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANT II TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS SALICYLATE TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
BARBITURATES TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS II TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS I TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
ANTICONVULSANTS TOXICOLOGY CONTROL1980-04-29

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